Device and method for assisting end-to-side anastomosis

ABSTRACT

Disclosed herein are embodiments of devices and methods for forming a seal covering an incision in tissue. In some embodiments, a deformable member can be loaded into a catheter and inserted into the tissue incision. The deformable member can unfold into a cup-shape which can form a seal around the incision during a procedure. Once the procedure is finished, the deformable member can be drawn back into the tube.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a divisional of U.S. application Ser. No.14/795,146, filed Jul. 9, 2015, now U.S. Pat. No. 10,178,993, whichclaims the benefit of U.S. Provisional Application No. 62/023,719, filedJul. 11, 2014, the entirety of all of which are hereby incorporated byreference. Any and all applications for which a foreign or domesticpriority claim is identified in the Application Data Sheet as filed withthe present application are hereby incorporated by reference under 37CFR 1.57.

BACKGROUND Field

Disclosed herein are embodiments of a device and method for creating aseal around an opening, such as a tissue opening, and in someembodiments for assisting end-to-side anastomosis.

Description of the Related Art

Currently, the standard practice in performing a coronary artery bypasssurgical procedure is to open the patient's chest, place the patient ona cardiopulmonary bypass (heart-lung) machine, stop the heart frombeating, and then attach the coronary artery bypass graft(s) to theaorta and coronary arteries. The heart-lung machine is needed tomaintain the blood circulation through the patient and to provide gasand heat exchange surfaces. Typically, the blood is cooled using theheart-lung machine to slow down the metabolism of the patient.Additionally, the blood is oxygenated and carbon dioxide is allowed tobe released from the blood. The aorta is usually clamped proximal to theentrance point of the blood from the heart-lung machine.

There can be numerous complications with stopping the patient's heartand using a heart-lung machine. For example, the heart-lung machinetypically needs to be primed with blood. This is usually done with bloodfrom a blood bank which can be contaminated with infectious agents suchas the HIV virus. Further, the heart-lung machine can lyse red bloodcells and destroy platelets causing anemia or increasing the risk ofhemorrhage. Additionally, the clamping of the aorta can release plaqueinto the blood stream, which can cause a stroke or a peripheral vascularincident.

Another technique is to partially cross-clamp the aorta with a “U”shaped clamp such that a small blood tunnel is created and an area ofblood stasis is created for making a proximal anastomosis site. Thistechnique eliminates the heart-lung machine, but increases the risk ofplaque releasing into the blood stream.

SUMMARY

Disclosed herein are embodiments of a device and method for sealing anopening in body tissue. In some embodiments, the device and method maybe used to create a seal around an incision or opening in a tissue wall,for example an incision or opening in a blood vessel. In certainembodiments, such devices and methods may be useful to perform anend-to-side anastomosis procedure on the aorta or other blood vessel.

In one embodiment, a device for sealing an opening in body tissuecomprises: a hollow elongated member comprising a proximal end and adistal end and having a lumen extending therethrough, wherein the distalend of the hollow elongated member is configured to extend through theopening in the body tissue; a shaft member configured to fit within thelumen of the hollow elongated member; and a deformable sealing membercoupled to a distal portion of the shaft member at a coupling point, thedeformable sealing member comprising a flexible cover portion coupled tothe distal portion of the shaft at the coupling point and a sealingring. The deformable sealing member is configured to move from a firstconfiguration to a second configuration, and from a second configurationto a third configuration. In the first configuration, the deformablesealing member is held within the lumen of the hollow elongated member,wherein the coupling point is located distal to the sealing ring. In thesecond configuration, the deformable sealing member is positioned distalto and outside of the lumen of the hollow elongated member, and whereinmovement of the deformable sealing member from the first configurationto the second configuration causes the sealing ring to enlarge to adimension larger than that of the hollow elongated member and theflexible cover portion to have generally a cup-like shape with anopening that faces proximally, wherein the sealing ring when enlarged isconfigured to seal against tissue surrounding the opening in the bodytissue. In the third configuration, the deformable sealing member isheld within the lumen of the hollow elongated member, wherein thesealing ring is located distal to the coupling point.

In some embodiments, the shaft member can comprise a first portion and asecond portion, the first and second portions being removably detachedfrom one another. In some embodiments, the device can be reusablewithout adding further components.

In some embodiments, the sealing ring can be magnetic. In someembodiments, the device can further comprise a magnetic ring on theoutside of the body tissue, wherein the magnetic ring can be configuredto magnetically attract the sealing ring so that the deformable sealingmember forms a seal around the opening in the body tissue. In someembodiments, the seal can remain without any other forces acting on thedeformable member. In some embodiments, the magnetic ring can beattached to the shaft member or the hollow elongated member.

In some embodiments, the deformable sealing member can expand upondistal movement outside of the hollow elongated member. In someembodiments, the hollow elongated member can comprise an internaltapered portion at the distal end configured to facilitate movement ofthe deformable sealing member from the second configuration to the thirdconfiguration. In some embodiments, in the second configuration thesealing ring can be configured to seal against an opening in a bloodvessel for creating an anastomosis site.

Also disclosed herein are embodiments of a device for sealing an openingin body tissue, the device comprising a hollow elongated membercomprising a proximal end and a distal end and having a lumen extendingtherethrough, wherein the distal end of the hollow elongated member isconfigured to extend through the opening in the body tissue. The devicefurther comprises a shaft member configured to fit within the lumen ofthe hollow elongated member. A deformable sealing member is coupled to adistal portion of the shaft member at a coupling point, the deformablesealing member comprising a magnetic ring and a flexible cover portion,the deformable sealing member configured to form a seal with the bodytissue surrounding the opening, wherein the deformable sealing member ismoveable from a first configuration within the hollow elongated memberto a second configuration wherein the magnetic ring engages a first sideof body tissue surrounding the opening. A magnetic portion is configuredto be located on a second side of body tissue opposite the first side,wherein the magnetic portion is configured to magnetically attract themagnetic ring, thus forming the seal.

In some embodiments, the magnetic portion can be attached to either thehollow elongated member or the shaft member. In some embodiments, themagnetic portion can be shaped generally the same as the magnetic ring.

Further disclosed herein are embodiments of a method for creating ananastomosis site along a wall of a blood vessel without interrupting theflow of blood through the blood vessel. The method comprises inserting ahollow elongated member through an opening in the wall of the bloodvessel. A deformable sealing member located within the hollow elongatedmember is advanced into the blood vessel, wherein after advancing, thedeformable sealing member is located distal to the hollow elongatemember and expands from a compressed configuration to an enlargedconfiguration. The deformable sealing member is moved proximally tocreate a seal between the deformable sealing member and the wall of theblood vessel, the seal surrounding the opening in the wall of the bloodvessel. The deformable sealing member may be removed from the bloodvessel by moving the deformable sealing member into the hollow elongatedmember, wherein the deformable sealing member is inverted when movedinto the hollow elongated member.

In some embodiments, after advancing, the deformable sealing member canexpand from a compressed configuration to an enlarged configurationhaving a cup shape with a sealing ring located at a rim of the cupshape. In some embodiments, the method can further comprise enlargingthe opening in the wall of the blood vessel after creating the seal. Insome embodiments, the method can further comprise suturing a bypassgraft to the hole in the blood vessel. In some embodiments, the methodcan further comprise removing the hollow elongated member from the bloodvessel between sutures used to attach the bypass graft to the hole inthe blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of an embodiment of a device for sealingan opening.

FIG. 2 illustrates a cross-section view of an embodiment of a device forsealing an opening.

FIG. 3 illustrates a cross-sectional side view of an embodiment of adeformable member.

FIG. 4 illustrates a proximal to distal view of an embodiment of adeformable member.

FIG. 5 illustrates a compressed first configuration of an embodiment ofa deformable member.

FIG. 6 illustrates an open or expanded second configuration of anembodiment of a deformable member.

FIG. 7 illustrates a closed third configuration of an embodiment of adeformable member.

FIG. 8 illustrates an incision formed in a blood vessel.

FIG. 9 illustrates a configuration of an embodiment of a deformablemember in a deformable hollow tube.

FIG. 10 illustrates a deformable member inserted into a blood vesselprior to expansion.

FIG. 11 illustrates a deformable member inserted into a blood vesselafter expansion.

FIG. 12 illustrates an embodiment of a deformable member partiallywithdrawn within a hollow tube.

FIG. 13 illustrates an embodiment of a deformable member fully withdrawnwithin a hollow tube.

FIGS. 14-15 illustrate the suturing of a blood vessel graft and removalof a deformable member.

FIGS. 16-17 illustrate embodiments of the internal structure of a tube.

FIG. 18 illustrates an embodiment of a detachable shaft.

FIG. 19 illustrates an embodiment of a magnetic deformable member.

DETAILED DESCRIPTION

Disclosed herein are embodiments of devices that can be used to providea seal and an anastomosis site for incisions in tissue. Accordingly, anoperator could operate on the tissue that is sealed without causingmajor blood leakage between the inside and outside of the tissue.Advantageously, this can remove the need for certain tools, such as aheart-lung machine, thus reducing the overall risk to the patient. Thus,embodiments of the disclosure can greatly reduce the risks associatedwith coronary artery bypass surgical procedures.

Specifically, certain embodiments of the devices and methods describedherein make use of a flexible, deformable, and optionally reusablemember having a generally cup or umbrella shape which can be fit withina catheter, or other elongate tube such as a hypotube, in a compressed,or delivery, configuration. The member can be released in a desiredlocation to expand and seal over an incision in tissue.

As used herein, “cup,” “cup-shape,” “cup-like shape” and similarlanguage is intended to include any shape, including an umbrella shape,half-sphere shape, pyramidal shape, or cone shape, which forms anenclosed volume with an opening facing away from the enclosed volume.Thus, a generally cup shape includes shapes including, but not limitedto rounded, spherical, conical and cylindrical shapes.

Generally, embodiments of the deformable member disclosed herein may beprovided on the distal end of a shaft, and both the deformable memberand the shaft may be positioned within an elongate tube. This assemblycomprising the deformable member, the shaft and the elongate tube may bedelivered into an opening in bodily tissue, for example, into the wallof a blood vessel or an artery. Upon the application of a force, forexample a distal force away from an operator, the deformable member canexit the tube and open into an enlarged configuration, wherein a cup isformed having an opening which faces proximally toward the shaft towhich the flexible member is attached. The shaft can then be advancedproximally (e.g., toward the operator) to draw a rim of the cup againstthe wall of the artery or other bodily tissue, and thus around the entrypoint of the shaft and the tube. To withdraw the flexible member, aproximal force can be applied to the shaft, thus withdrawing thedeformable member back into the tube in a generally opposite position aswhen it was inserted. In some embodiments, as the deformable member iswithdrawn, the cup-shape of the deformable member is inverted.

While blood vessels/arteries are specifically described below withembodiments of the device, the device may conceivably be used in avariety of other operations involving incisions in blood vessels ororgans, or other openings in bodily tissue (whether naturally occurring,abnormal openings, or man-made), and the particular type of tissue isnot limiting.

Handle

FIGS. 1-2 illustrate an embodiment of a device, which in one embodiment,may be an anastomosis assistance device. As shown, a translatable piston17 can be slidably retained within a handle 16. The handle 16 can begenerally hollow and can have sufficient room for the piston 17 totranslate through the handle, though the particulars of the handle 16 isnot limiting. The handle 16 can allow the operator to have a referencepoint on when the deformable member 14, or deformable sealing member,has been fully expanded, as discussed below. For example, in someembodiments the handle 16 can include visual, sensory, or auditory cluesfor the location of the piston 17 within the handle 16. In someembodiments, the handle 16 can include a releasable lock when the piston17 is in the fully compressed position. In some embodiments, the handle16 can include grips or projections for ease of holding by an operator.

As shown in the cut-out view of FIG. 2, in some embodiments the handle16 can also contain a spring 18, which can be located at the distal endof the piston 17. Accordingly, when the piston 17 is translateddistally, thereby releasing the deformable member 14 from hollow tube12, the spring 18 can be put under compression. Upon release of thepiston 17, for example upon release of tab 22 from hole 21, the spring18 can act to press the piston 17 proximally, thereby translating thedeformable member 14 proximally back into the hollow tube 12. In someembodiments, a spring 18 is not used, and an operator can pull back onthe piston 17.

Attached to the distal center of the handle 16 is a hollow tube 12, orhollow elongated member, having a lumen extending therethrough. Thehollow tube 12 can extend distally away from the handle 16. The hollowtube 12 can be formed of either a flexible material, such as a catheter(e.g., a plastic catheter), or can be generally rigid, such as ahypotube. Thus, the hollow tube 12 can be used to guide the translatableshaft 11 discussed below. Further, the hollow tube 12 can be of anydesired length or thickness to the operator, depending on the type ofapplication it is used for, and thus the length or thickness is notlimiting. In some embodiments, the hollow tube 12 can be swapped outdepending on the desired configuration by an operator. The hollow tube12 may also comprise multiple sections tubing attached or connected toeach other, wherein the different sections of tubing may be made of thesame or different materials. The hollow tube 12 may not be moved bytranslation of the piston 17, and thus can remain stationary withrespect to the handle 16.

A translatable shaft 11, or wire, can be attached to the center of thepiston 17 and can extend distally away from the handle 16 and piston 17.Thus, motion of the piston 17 can translate the translatable shaft 11through the hollow tube 12 and into a desired location in a patent. Thedistal end of the translatable shaft 11 can be attached to thedeformable member 14, as further discussed in detail below. Thetranslatable shaft 11 can traverse through a lumen of the hollow tube12. In some embodiments, the translatable shaft 11 can be made out of adurable material such as stainless steel or plastic. In someembodiments, the translatable shaft 11 can be relatively rigid, and thuscan be configured to translate the deformable member 14 as the piston 17is translated. In some embodiments, the translatable shaft 11 can beflexible in order to follow any curvature of the hollow tube 12. In someembodiments, the translatable shaft 11 can be longer than the hollowtube 12, thus allowing the deformable member 14 to move in and out ofthe hollow tube 12 upon application of a force on the translatablepiston 17.

While the above describes the use of a handle, spring, and pistonconfiguration, other types of configurations can be used with thedisclosure and the above configuration does not limit the disclosure.For example, a physician could physically hold the hollow tube 12 andtranslatable shaft 11 without the handle 16, and thus the handle 16could be optional. Further, in some embodiments the hollow tube 12 andtranslatable shaft 11 can be connected to electronic components whichcan automatically move the translatable shaft 11, or an operator canoperate the electronic components. For example, a button or switch couldbe used to actuate the translatable shaft 11.

Deformable Member

A deformable member 14 can be attached to a distal end of translatableshaft 11 in order to provide a seal around a tissue opening. As shown inFIG. 3, the deformable member 14 can be formed generally from twocomponents, a membrane 32 and ring 34, though other components can beused as well. Further, the membrane 32 and ring 34 can be one integrallyformed component, or can be made of a plurality of other components.

FIGS. 3-4 show the deformable member 14 in the enlarged configuration(e.g. the expanded or deployed position), which is the position thedeformable member 14 would be when forming a seal around a tissueincision. In some embodiments, the deformable member 14 can be formedfrom a flexible cover material, such as membrane 32, generallysurrounding and/or attached to a body portion such as a sealing ring 34.

The ring 34 can be generally more rigid than that of the membrane 32,though the ring 34 can still be sufficiently flexible to fit within thehollow tube 12. Thus, the ring 34 can provide shape stability to thering 34. The ring 34 can be configured to bend when a compressive stressis applied, and then return to its original shape upon the removal ofthe compressive stress. Thus, the ring 34 can be self-expanding. Thering 34 can be formed of a more rigid biocompatible material, such as ametal or plastic, though can still be flexible enough to fit withinhollow tube 12. In some embodiments, the ring 34 can be a wire frame. Insome embodiments, the ring 34, can be a thickened or less flexibleportion of the membrane 32, and thus can be essentially the samematerial as the membrane 32.

The membrane 32 can form a cup-like configuration upon full expansion,as shown in the cross-section of FIG. 3, with the ring 34 located at therim of the cup-shaped membrane. The cup-like configuration can be, forexample, an umbrella-like configuration. In some embodiments, thecup-like configuration may not have a convex outer surface, but couldalso have straight surfaces or concave surfaces (such as shown in FIG.11). As shown, the cup-like configuration can form a cavity 19(anastomosis site) in which an operator can operate on without excessiveblood loss. The membrane 32 can be formed of a single piece of material,or may comprise multiple pieces of material, and may further comprisesupports that help hold the shape of the membrane when expanded. Similarto the ring 34, the membrane 32 can be compressed into a small shapeupon the application of a compressive force. Upon removal of thecompressive force, the membrane 32 can return to its original shape, andcan thus be self-expanding. In some embodiments, the membrane 32 is notself-expanding and expands based on the ring 34. The membrane 32 can bemade out of a flexible compliant biocompatible material such as, forexample, polyurethane, Dynaflex, or silicone, and the type of materialis not limiting.

In some embodiments, the membrane 32 can be made from a flexible braidedtube or sleeve, such as with one-quarter inch expandable mesh. In someembodiments, the entire deformable member 14 can be coated with aflexible, impermeable material, such as silicone, to make the deformablemember 14 impermeable to the flow of blood. In some embodiments, thesilicone coating may alternatively be applied to only a distal half ortwo-thirds of the deformable member 14. The particular portion of thedeformable membrane 14 covered by silicone is not limiting. In someembodiments, the membrane 32 is solid so that blood cannot flow through.

In some embodiments, the ring 34 and membrane 32 can be formed of thesame material. In some embodiments, the ring 34 and membrane 32 can beintegrally formed. In some embodiments, the ring 34 can be attached tothe membrane 32 through, for example, adhesive or sewing, though thetype of attachment is not limiting. In some embodiments, the ring 34 isno more than the edge of the membrane 32.

As shown in the cutout viewpoint of FIG. 3, the translatable shaft 11can be inserted into the middle of the cup-shaped membrane 32.Specifically, the translatable shaft 11 can be connected to the distalend 35 of the membrane 32 at a coupling point 15. In some embodiments,as shown in FIG. 3, the translatable shaft 11 can have an expandeddistal tip 13, such as an arrow or mushroom shaped tip, which can fitwithin a slot 36 at the distal end 35 of the deformable member 14. Insome embodiments, the translatable shaft 11 can be permanently attachedto the deformable member 14. In some embodiments, the translatable shaft11 can be removable attached to the deformable member 14. In someembodiments, an adhesive can be used to connect the translatable shaft11 to the membrane 32. In some embodiments, physical forces, such asfriction, can be used to connect the translatable shaft 11 to themembrane 32. Thus, an adhesive may not be used in some embodiments. Theattachment means is not limiting.

FIG. 4 shows a viewpoint looking into the cup-shaped membrane 32 towardsthe distal end 35 of the deformable member 14. As shown, the ring 34 canbe generally circular in shape, though other configurations, such assquares or ovals, can be used, and the shape is not limiting.

FIGS. 5-7 shows the deformable member 14 in different configurationswhich would generally occur during use of embodiments of the device. Asshown, the hollow tube 12 can radially compress the deformable member 14in FIGS. 5 and 7, thus forming the particular shape.

FIG. 5 illustrates a first configuration of the deformable member 14 asit can look inside of the hollow tube 12 prior to expansion in a bloodvessel or other body location. As shown, the membrane 32 and ring 34 areradially compressed by the hollow tube 12, allowing the deformablemember 14 to fit within, and slide within, the hollow tube 12. In someembodiments, a lubricant can be used on the inner surface of the hollowtube 12. In some embodiments, the deformable member 14 could becompressed even further than what is shown in FIG. 5, so that thediameter of the deformable member 14 is approximately that of thetranslatable shaft U. Thus, the deformable member 14 would be able tofit into very small incision spaces. As shown, in this compressedconfiguration, the distal end 35 (and the coupling point 15) of thedeformable member 14 is distal to the ring 34.

FIG. 6 illustrates a second configuration of the deformable member 14upon release from the hollow tube 12. As shown, the member 14 achieves agenerally cup-like configuration upon expansion, with the ring 34expanding out to its full diameter. The member 14 can in one embodimentexpand without any outside force, and thus can expand purely based onthe release of the compression from the hollow tube 12. In otherembodiments, a mechanism may be included that holds the deformablemember in its collapsed configuration even after being released fromhollow tube 12, which allows the deformable member 14 to expand after ithas been moved relatively distally out of the hollow tube 12. As shown,when expanded, the deformable member 14 can have the same orientation asshown in FIG. 5. Thus, as illustrated in FIG. 6, the coupling point 15between the translatable shaft 11 and the deformable member 14 is stilllocated distal to the ring 34.

FIG. 7 illustrates a third configuration of the deformable member 14 asit would look inside of the hollow tube 12 when withdrawn into thehollow tube 12 after expansion in the blood vessel or other bodylocation, discussed below. As shown, the configuration and/ororientation is generally opposite of that shown in FIG. 5, with the ring34 being distal to the membrane 32 and the cup-shaped member beinginverted. Therefore, the distal end 35 (and coupling point 15) of thedeformable member 14 is proximal to the ring 34.

After removal from the blood vessel or other body location, thedeformable member 14 can be reoriented by an operator back into itsoriginal position, and can be relocated within the hollow tube 12 forfurther use, or it may be disposed. Thus, in some embodiments the devicecan be reusable. In some embodiments, the device may be able to handledifferent sterilization procedures.

Method of Use

One embodiment of the disclosed device can be used for bypassing ofblood vessels and arteries. Discussed in detail below is a configurationused for coronary artery bypass grafting, though embodiments of thedisclosed device can be used with other vessels and organs as well, andwith other bodily openings, and the disclosed method is not limited tothe particular procedure described below.

In coronary artery bypass grafting, a patient can be prepped and accessto the aorta can be established by either an open chest procedure, portaccess, or via a small lateral incision in the ribs. As shown in FIG. 8,once the aorta is accessed, a small incision 82 can be made in a bloodvessel, such as the aorta, at a proximal anastomosis site for a coronaryartery bypass procedure. If the incision 82 is not sealed, blood willcontinuously leak out, leading to potential complications during thesurgery.

As shown in FIG. 9, the deformable member 14 can first be located withinthe hollow tube 12. FIG. 9 shows that the hollow tube 12 expands aroundwhere the deformable member 14 is located. However, in some embodimentsthe hollow tube 12 would not necessarily change dimensions based on thelocation of the deformable member 14. This is especially true when amore rigid tube is used, such as a hypotube, as compared to a catheter.As shown, the member 14 in the hollow tube 12 has a shape generallysimilar to that shown in FIG. 5.

As shown in FIG. 10, the distal end of hollow tube 12 containing thedeformable member 14 and translatable shaft 11 can be inserted through ahole 82 in a blood vessel so that the distal opening of the hollow tube12 is located in the blood vessel. Upon insertion of the end of thehollow tube 12, the deformable member 14 can be released from theopening of the hollow tube 12. This can be done in a number of differentways, none of which are limiting. In some embodiments, the hollow tube12 can be pulled out of the blood vessel by a proximal force, while thedeformable member 14 and translatable shaft 11 can be located and heldin the same position. In some embodiments, the deformable member 14 canbe pushed out of the hollow tube 12 through a distal force applied onthe translatable shaft 11. Once released, the hollow tube 12 can then bepulled back from the blood vessel by a proximal force (shown in FIG.11). FIG. 10 shows the deformable member 14 prior to expansion in theblood vessel, but after being partially released from the hollow tube12. In some embodiments, the deformable member 14 may already beexpanding in this position, and thus may be partially expanded.

Upon release, the deformable member 14 can expand into an umbrella, orcup, shape which can cover up the incision 82 made in the blood vesselas shown in FIG. 11. As shown, the hollow tube 12 can be pulled backfrom the blood vessel. Accordingly, the deformable member 14 can belocated on the interior of the blood vessel. An operator can then applyproximally directed tension to the deformable member 14 to seal theedges or the rim of the deformable member 14 to the inner wall of theblood vessel. In some embodiments, the deformable member 14 onlyoccludes the area of the aorta around the incision 82 and does nototherwise obstruct the flow of blood in the aorta. Blood flows from theheart, past the distal end of the deformable member 14, and to theperipheral tissues. Thus, the deformable member 14 prevents blood fromescaping the surgical site but does not require the heart to be stopped.The operator can then operate on the area covered by the deformablemember 14.

When the operator desires the deformable member 14 to be removed, thehollow tube 12 can be inserted back into the blood vessel through theincision. In some embodiments, the hollow tube 12 does not enter theblood vessel, but remains outside or in line with the wall of the bloodvessel. The deformable member 14 can then be positioned back within thehollow tube 12. In some embodiments, the hollow tube 12 can be pushedinto the blood vessel while the member 14 remains in the same location.This causes the deformable member 14 to fold around and be brought intothe hollow tube 12, as shown in FIG. 12. In some embodiments, the hollowtube 12 remains stationary and a proximal force is applied to thetranslatable shall 11, thus bringing the deformable member 14 into thehollow tube 12. In some embodiments, the deformable member 14 is broughtfully within the hollow tube 12. In some embodiments, the deformablemember 14 is brought partially within the hollow tube 12. Upon enteringthe hollow tube 12, the deformable member 14 is generally in theopposite position (e.g., inverse position) as when it was first insertedinto the blood vessel, as shown in FIG. 13.

When the deformable member 14 is located inside the blood vessel, thering 34 of the member 14 can rest against the surface of the bloodvessel (the inner surface of the vessel in FIG. 14, shown as element142). Therefore, the incision 82 can be sealed from the path of theblood in the blood vessel, preventing blood from leaking out of theblood vessel. Once the seal has been formed to provide a working area,the operator can widen the incision as needed to create a proximalanastomosis site for a coronary bypass graft. The operator then canloosely suture one end of a coronary artery bypass graft (typically asection of a saphenous vein) to the hole, shown in FIG. 14. The operatorcan allow enough slack on the suture to be able to remove the device (atthis point the hollow tube 12, including the deformable member 14), asshown in FIG. 15.

The operator can then remove the hollow tube 12 from the aorta aroundthe loose sutures and pulls the sutures around the graft tight to givethe graft a good seal. The other end of the coronary artery bypass graftcan be attached to a surgically created hole in a coronary artery whilethe heart is still beating before, during, or after the aorticanastomosis. The rest of the coronary bypass procedure can be completedusing standard techniques.

Tube Configuration

FIG. 16 illustrates an example embodiment of the hollow tube 12. Asshown, the hollow tube 12 can have an outer wall 162 and an inner wall164 spaced away from the outer wall 162. Near the distal opening 166, agenerally tapered surface 168 can extend from the inner wall 164 to theouter wall 162. This tapered surface 166 can help direct and positionthe deformable member 14 when being pushed in or out of the hollow tube12, and can prevent the deformable member 14 from catching. In someembodiments, the surface between the outer wall 164 and the inner wall162 need not be tapered, and the surface can be formed of generallystraight edges with steps 170, as shown in FIG. 17. In some embodiments,the edges are generally curved. In some embodiments, the hollow tube 12can be a standard catheter or hypotube, and thus no steps or tapers maybe used.

In some embodiments, the hollow tube 12 and/or the translatable shaft 11can be detachable, as shown in FIG. 18, at a detachable section 186.Accordingly, the piston 17 and handle 16, along with a portion of thehollow tube 12 and the translatable shaft 11 can be withdrawn from theportion having the deformable member 14. The detachable section 186 canbe located anywhere along the translatable shaft 11 and/or hollow tube12. In some embodiments, only the translatable shaft 11 is detachable,and the hollow tube 12 can be drawn away from the deformable member 14,thus leaving a portion of the translatable shaft 11 and the deformablemember 14 inside a patient. This can allow more maneuverability for anoperator of the device as there are fewer parts that would be in the wayduring an operation. Upon completion of whatever procedure an operatoris performing, the pieces can be reattached, and thus the procedure forwithdrawing the deformable member 14, as discussed above, can takeplace.

The attachment of the portions of the translatable shaft 11 and/orhollow tube 12 are not limiting, and different attachment means can beused. In some embodiments, male and female screw portions 182/184 can beused, as shown in FIG. 18. In some embodiments, snaps, hooks, friction,or other means of detachable attachment can be used. In someembodiments, the portions can be reattached just by using the handle 16.In some embodiments, an operator can directly attach the portions byholding onto both portions and connecting them.

Magnetic Deformable Member

In some embodiments, magnetism can be used to hold the deformable member14 onto a blood vessel. FIG. 19 shows an example of such a configurationin a blood vessel 190. As discussed above, the deformable member 14 cancomprise a generally circular, flexible ring 34 configured to expandinto the cup shape upon removal of all outside forces. In someembodiments, the ring 34 can be formed of a magnetic material, such as amagnetic metal, and the type of magnetic material is not limiting.

Outside of the blood vessel 190, the device can have an outer magneticportion 192 having a magnetic material configured to attract themagnetic material in the ring 34 of the deformable member 14. In someembodiments, the outer magnetic portion 192 may be generally sized tomirror the size and shape of the ring 34. In some embodiments, the outermagnetic portion 192 may be substantially larger than the ring 34, thusfacilitating magnetic response even if perfect alignment is not made. Insome embodiments, the outer magnetic portion 192 may be separate fromthe translatable shaft 11 and/or hollow tube 12. Therefore, uponinsertion and expansion of the deformable member 14, the outer magneticportion 192 may be placed outside the blood vessel 190. For example, theouter magnetic portion 192 may be ring shaped with a hinge or gap,wherein the outer magnetic portion 192 can surround the translatableshaft 11, and the hinge can be closed. In some embodiments, the outermagnetic 192 portion may be connected to the translatable shaft 11and/or hollow tube 12.

Upon placement of the outer magnetic portion 192 onto the blood vessel190 in a location corresponding to the ring 34 of the deformable member14, the magnetic attraction between the pieces can be sufficient as toform a fluid tight seal on the inside of the blood vessel 190, thuspreventing blood from escaping through the incision. Thus, an operatorneed not keep providing a proximal force to the deformable member 14 tokeep the deformable member 14 in place, allowing an operator free use ofboth hands. This can be especially advantageous for embodiments wherethe translatable shaft 11 can be disconnected into two portions, asdescribed above. Thus, numerous components can be removed and moved outof the way so that an operator can perform actions with less equipment.Further, the outer magnetic portion 192 can act as a guide so that anoperator does not suture into the deformable member 14 during operation.

In some embodiments, the outer magnetic portion 192 can be attached to aremoval element 194. This removal element 194 can be, for example, astring or rod. Accordingly, when an operator desires to remove thedeformable member 14 from the blood vessel 190, the operator can providea force on the removal element 194 away from the blood vessel 190, thusovercoming the magnetic attraction between the deformable member 14 andthe outer magnetic portion 192. Upon removing the outer magnetic portion192, the deformable member 14 can be removed from the blood vessel 190as discussed in the procedures above. The removal element 194 can alsobe used to help locate the outer magnetic portion 192 if it were tobecome unattached. In some embodiments, the removal element 194 canattach the outer magnetic portion 192 to either the translatable shaft11 or the hollow tube 12, therefore keeping all components together.

Embodiments of the disclosed device can provide for numerous advantages.Because the device can be inserted and removed from the blood vesselwithout damaging any of the components, it can be used at multiple sitesduring a surgery. This can be especially advantageous as many operationsrequire numerous anastomosis sites. As the device is reusable, this canreduce the overall costs of a procedure in comparison to other deviceswhich, for example, unravel during use and cannot be used again.

In some embodiments, the above disclosed configuration can be used witha hole punch device, as described in detail in U.S. Pat. No. 6,409,739,hereby incorporated by reference in its entirety. Additionally, othercomponents described in detail in U.S. Pat. No. 6,409,739 can be usedwith configurations of the above device as well.

From the foregoing description, it will be appreciated that an inventiveproduct and approaches for medical devices are disclosed. While severalcomponents, techniques and aspects have been described with a certaindegree of particularity, it is manifest that many changes can be made inthe specific designs, constructions and methodology herein abovedescribed without departing from the spirit and scope of thisdisclosure.

Certain features that are described in this disclosure in the context ofseparate implementations can also be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation can also be implemented inmultiple implementations separately or in any suitable subcombination.Moreover, although features may be described above as acting in certaincombinations, one or more features from a claimed combination can, insome cases, be excised from the combination, and the combination may beclaimed as any subcombination or variation of any subcombination.

Moreover, while methods may be depicted in the drawings or described inthe specification in a particular order, such methods need not beperformed in the particular order shown or in sequential order, and thatall methods need not be performed, to achieve desirable results. Othermethods that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionalmethods can be performed before, after, simultaneously, or between anyof the described methods. Further, the methods may be rearranged orreordered in other implementations. Also, the separation of varioussystem components in the implementations described above should not beunderstood as requiring such separation in all implementations, and itshould be understood that the described components and systems cangenerally be integrated together in a single product or packaged intomultiple products. Additionally, other implementations are within thescope of this disclosure.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include or do not include, certain features, elements,and/or steps. Thus, such conditional language is not generally intendedto imply that features, elements, and/or steps are in any way requiredfor one or more embodiments.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than or equal to 10% of, within less than or equal to 5% of, withinless than or equal to 1% of, within less than or equal to 0.1% of, andwithin less than or equal to 0.01% of the stated amount.

Some embodiments have been described in connection with the accompanyingdrawings. The figures are drawn to scale, but such scale should not belimiting, since dimensions and proportions other than what are shown arecontemplated and are within the scope of the disclosed inventions.Distances, angles, etc. are merely illustrative and do not necessarilybear an exact relationship to actual dimensions and layout of thedevices illustrated. Components can be added, removed, and/orrearranged. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with various embodiments can be used in allother embodiments set forth herein. Additionally, it will be recognizedthat any methods described herein may be practiced using any devicesuitable for performing the recited steps.

While a number of embodiments and variations thereof have been describedin detail, other modifications and methods of using the same will beapparent to those of skill in the art. Accordingly, it should beunderstood that various applications, modifications, materials, andsubstitutions can be made of equivalents without departing from theunique and inventive disclosure herein or the scope of the claims.

What is claimed is:
 1. A method for creating an anastomosis site along awall of a blood vessel without interrupting the flow of blood throughthe blood vessel, the method comprising: inserting a hollow elongatedmember through an opening in the wall of the blood vessel; advancing adeformable sealing member located within the hollow elongated memberinto the blood vessel, wherein after advancing, the deformable sealingmember is located distal to the hollow elongate member and expands froma compressed configuration to an enlarged configuration having a cupshape with a magnetic sealing ring located at a rim of the cup shape;and creating a seal between the deformable sealing member and the wallof the blood vessel by moving the deformable sealing member proximallyand applying a magnetic ring outside the wall of the blood vessel tomagnetically attract the sealing ring, the seal surrounding the openingin the wall of the blood vessel, and the cup shape forming a cavity thatdefines the anastomosis site.
 2. The method of claim 1, furthercomprising enlarging the opening in the wall of the blood vessel aftercreating the seal.
 3. The method of claim 1, further comprising suturinga bypass graft to the opening in the wall of the blood vessel.
 4. Themethod of claim 3, further comprising removing the hollow elongatedmember from the blood vessel between sutures used to attach the bypassgraft to the opening in the wall of the blood vessel.
 5. The method ofclaim 1, further comprising applying a force on a removable elementattached to the magnetic ring away from the sealing ring to detach themagnetic seal from the sealing ring so as to remove the deformablesealing member from the blood vessel.
 6. The method of claim 1, whereinthe advancing comprises advancing a shaft member that is fit within alumen of the hollow elongated member, the shaft member coupled to thedeformable sealing member.
 7. The method of claim 1, further comprisingremoving the deformable sealing member permanently from the blood vesselby moving the deformable sealing member into the hollow elongatedmember, wherein the deformable sealing member is inverted when movedinto the hollow elongated member.
 8. A method for creating ananastomosis site along a wall of a blood vessel without interrupting theflow of blood through the blood vessel, the method comprising: insertinga hollow elongated member through an opening in the wall of the bloodvessel, a distal end of the hollow elongated member configured to extendthrough the opening; advancing a deformable sealing member locatedwithin the hollow elongated member into the blood vessel, wherein afteradvancing, the deformable sealing member is located distal to the hollowelongate member and expands from a compressed configuration to anenlarged configuration, the deformable sealing member comprising aflexible cover; creating a seal between the deformable sealing memberand the wall of the blood vessel by moving the deformable sealing memberproximally to engage a magnetic ring of the deformable sealing memberwith a first side of body tissue surrounding the opening; applying amagnetic portion on a second side of body tissue opposite the first sideto magnetically attract the magnetic ring; detaching the magneticportion from the magnetic ring; and removing the deformable sealingmember from the blood vessel by moving the deformable sealing memberinto the hollow elongated member, wherein the deformable sealing memberis inverted when moved into the hollow elongated member.
 9. The methodof claim 8, further comprising suturing a bypass graft to the opening inthe wall of the blood vessel.
 10. The method of claim 9, furthercomprising removing the hollow elongated member from the blood vesselbetween sutures used to attach the bypass graft to the opening in thewall of the blood vessel.
 11. The method of claim 8, wherein thedeformable sealing member in the enlarged configuration has a cup shapeforming a cavity, the cavity defining the anastomosis site.
 12. Themethod of claim 8, further comprising enlarging the opening in the wallof the blood vessel after creating the seal.
 13. The method of claim 8,wherein the magnetic portion is attached to the hollow elongated member.14. The method of claim 8, wherein the advancing comprises advancing ashaft member that is fit within a lumen of the hollow elongated member,the shaft member coupled to the deformable sealing member.
 15. Themethod of claim 14, wherein a distal portion of the shaft member ispermanently coupled to the deformable sealing member at a couplingpoint.
 16. The method of claim 15, wherein in the compressedconfiguration, the coupling point is located distal to the magneticring.
 17. The method of claim 15, wherein when the deformable sealingmember is inverted, the coupling point is located proximal to themagnetic ring.
 18. The method of claim 8, wherein the detachingcomprises applying a force away from the magnetic ring on a removableelement attached to the magnetic portion.